NCT03665155 · REGISTRY CONDITION SEARCH

First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2021-07-30

The purpose of this study is to test 89Zr-DFO-daratumumab, a new imaging agent, to demonstrate its safety and ability to take pictures of the myeloma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Age 21 years or greater * Histologically/Immunohistochemistry confirmed CD38-positive multiple myeloma * At least one tumor lesion on CT, MRI, or FDG PET/CT within 60 days of protocol enrollment * ECOG performance status 0 to 2 * For Phase II patients only: plan for initiation of standard-of-care daratumumab/lenalidomide therapy. Exclusion Criteria: * Life expectancy \< 3 months * Pregnancy or lactation * Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds. * History of anaphylactic reaction to humanized or human antibodies or a Grade 3 or 4 administration reaction during a daratumumab administration.
healthy Volunteers: false
minimum Age: 21 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality. Patients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients). After pharmacokinetics and radiation dosimetry are determined in phase I, additional patients will be enrolled in phase II.
intervention Names
Drug: 89Zr-daratumumab
Device: PET/CT scans
Other: Blood draws
label
89Zr-daratumumab
type
EXPERIMENTAL

interventions

arm Group Labels
89Zr-daratumumab
description
2 mCi of 89Zr-daratumumab will be administered on day 0.
name
89Zr-daratumumab
type
DRUG
arm Group Labels
89Zr-daratumumab
description
PET/CT images will be obtained on post-administration days 1, 2-4, 5-6, and/or 7-8 following administration of 89Zr-DFO-daratumumab to determine the optimal time point for imaging.
name
PET/CT scans
type
DEVICE
arm Group Labels
89Zr-daratumumab
description
Blood and serum samples will be weighed and counted in a scintillation well counter calibrated for 89Zr. Immediately before or after each PET/CT imaging session,
name
Blood draws
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

intervention Model Description

This is a phase I/II study with the goal to assess the feasibility of using the anti-CD38 monoclonal antibody daratumumab, labeled with Zirconium-89 (89Zr ) through deferoxamine (DFO), known as 89Zr-DFO-daratumumab, for PET imaging of multiple myeloma.

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 11
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Standardized uptake value (SUV) in various organs will be estimated from VOI analysis of clinical images and converted to activity-time curves. The areas under the activity-time curves will be derived by integration, converted to residence times, and used as input to the OLINDA/EXM dosimetry program to obtain absorbed dose estimates for normal tissues for all Phase I participants, regardless of study dose. Each participant underwent four PET/CT scans over the next 8 days, as well as blood chemistry and whole-body counts, to determine safety, tracer biodistribution, pharmacokinetics, and radiation dosimetry. Because 89Zr has a half-life of 78 hours, only a single administration of tracer was needed to obtain all four PET/CT scans for all Phase I participants. Results were combined because all received the same dose of tracer.
measure
Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants
time Frame
up to 19 months

Full study description

brief Summary: The purpose of this study is to test 89Zr-DFO-daratumumab, a new imaging agent, to demonstrate its safety and ability to take pictures of the myeloma.

Source references